PagePage#of10產(chǎn)品名可用性評價報告文件編號：編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6MedicalelectricalequipmentPart1—^:Generalrequirementsforsafety-CollateralStandard:UsabilityEN62366MedicaldevicesApplicationofusabilityengineeringtomedicaldevicesReportRefereneeNo。TOC\o"1-5"\h\zCompiledby(+signature):Approvedby(+signature):Dateofissue:CompanynameAddress:Testspecification:Standard:EN60601-1—6:2010,EN623662008TestitemdescriptionTOC\o"1-5"\h\zTradeMarkManufacturer:Model/TyperefereneeRatingsPossibletestcaseverdicts:-testcasedoesnotapplytothetestobject:N/A-testobjectdoesmeettherequirement:Pass(P)-testobjectdoesnotmeettherequirement:Fail(F)TestResult:Passed

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict4Generalrequirements總要求4。1ConditionsforapplicationtoMEEQUIPMENTME設(shè)備應(yīng)用條件TheMEEQUIPMENTshallprovideadequateUSABILITYsuchthattheRISKSresultingfromNORMALUSEandUSEERRORareacceptable^Seealso7.1。1and12.2ofthegeneralstandarc。ME設(shè)備應(yīng)提供充分的可用性^吏得由于正常使用和使用錯誤導(dǎo)致的風險是可以接受的?參見通用標準的7。1。1和12.2。4.2USABILITYENGINEERINGPROCESSforMEEQUIPMENTME設(shè)備的可用性工程程序AUSABILITYENGINEERINGPROCESScomplyingwithIEC62366shallbeperformed可用性工程程序按照IEC62366執(zhí)行?！猠stablishedaUSABILITYENGINEERINGPROCESS建立一個可用性工程程序；—establishedacceptaneecriteriaforUSABILITYand建立可用性驗收標準；和demonstratedthattheacceptaneecriteriaforUSABILITYhavebeenmet。證明可用性已達到驗收標準。4。3REPLACEMENTOFREQUIREMENTSGIVENINIEC62366IEC62366中的代替要求InadditiontorequirementsofIEC62366thefollowingreplacementsshallapply:ReplacethefirsttwoparagraphsincludingNOTES1and2ofClause6ofIEC623662007by:適用IEC62366除了以下的要求更換：將IEC62366:2007第6條款的前兩段包括備注1和2用以下內(nèi)容替換。TheinstructionsforuseshallincludeabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformaneecharacteristicsrelevantoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasaseparatedocument.設(shè)備的簡要描述，運行原理、與可用性相關(guān)的重要物理特性和性能應(yīng)包含在使用說明書中。如果技術(shù)說明書單獨提供，則相冋的信息也應(yīng)包含在技術(shù)說明書中。tTheinstructionsforuseshallcontainasummaryoftheapplicationspecification使用說明應(yīng)包含一個應(yīng)用規(guī)范的總結(jié)。EN62366

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：ClauseRequirement+TestResult—RemarkVerdict4GENERALREQUIREMENTS總要求4。1GeneralRequirements總要求4。1.1UsabilityEngineeringProcess可用性工程過程TheMANUFACTURERshallestablishdocumentandmaintainaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT，USERandothersrelatedtoUSABILITY。ThePROCESSshalladdressUSERinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT,including,butnotlimitedto:—transport;-storage；—installation；—operation;—maintenanceandrepair;and-disposal.制造商應(yīng)建立、形成文件和保持可用性工程過程，以便為患者、用戶和其他與可用性有關(guān)的人員提供安全性?該過程應(yīng)按照隨附文件描述用戶和醫(yī)療器械的交互，隨附文件包括（但不限于）:運輸；儲存；安裝；操作；維護和維修；處置。4。1。2Residualrisk剩余風險IftheusabilityengineeringprocessdetailedinthisInternationalStandardhasbeencompliedwithandtheacceptaneecriteriadocumentedintheusabilityvalqatqnplanhavebeenmet（see5。9）,then,forthepurposesofISO14971，theresidualrisksassociatedwithusabilityofthemedicaldeviceshallbepresumedtobeacceptable，unlessthereisobjectiveevidencetothecontrary.如果遵守了本標準中詳細規(guī)定的可用性工程過程和滿足了可用性確認計劃中形成文件的可接受準則（見5.9）,則對ISO14971來說，與醫(yī)療器械的可用性有關(guān)的剩余風險應(yīng)認為是可接受的，除非有相反的客觀證據(jù)。4。1.3InformationforSAfety安全性信息IfinformationforSAFETYisusedasaRISKCONTROLmeasure，theMANUFACTURERshallsubjectthisinformationtotheUSABILITYENGINEERINGPROCESSo如果安全性信息用作風險控制措施，制造商應(yīng)將此信息納入可用性工程過程。

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict4。2UsabilityEngineeringFile可用性工程文擋Theresultsoftheusabilityengineeringprocessshallberecordedintheusabilityengineeringfile。TherecordsandotherdocumentsthatformtheusabltyengneerngFILEmayformpartofotherdocumentsandfiles.可用性工程過程的結(jié)果應(yīng)記錄在可用性工程文檔中。構(gòu)成可用性工程文擋的記錄和其他文檔可以是其他文件和文檔的一部分。4。3ScalingoftheUsabilityEngineeringeffort用性工程工作范圍界定Theusabilityengineeringprocessmayvaryinformandextentbasedonthenatureofthemedqaldevice，itsintendedUSERanditsintendedUSE(seeD.3.2)。Inthecaseofthemodificationofamedicaldevicedesign,theusabilityengineeringprocessmaybescaleduporscaled-downbasedonthesignificaneeofthemodificationasdeterminedbytheresultsoftheRIsKanalysis(seeD.3.2.2)?？捎眯怨こ踢^程的形式和程度可根據(jù)醫(yī)療器械種類、其預(yù)期用戶和預(yù)期用途(見D3。2)的不同。對醫(yī)療器械的設(shè)計更改，可用性工程過程可以根據(jù)風險分析結(jié)果(見D3。2。2)所確定的更改的重要性而擴大或縮小工作范圍。5usabiltyengineeringprocess用性工程過程5.1Applicationspecification應(yīng)用規(guī)范ThemanufacturershallspecifytheapplicationoftheMEDICALDEVICEintheUSABILITYENGINEERINGFILE。制造商應(yīng)在可用性工程文檔中規(guī)定醫(yī)療器械的應(yīng)用。Thisspecificationshallinclude:一*intendedmedicalindication；一intendedPATIENTpopulation；一intendedpartofthebodyortypeoftissueappliedtoorinteractedwith；-*intendedUSERPROFILE；一*intendedconditionsofuse;and一*operatingprinciple。此規(guī)范應(yīng)包括：-*預(yù)期的醫(yī)療適應(yīng)癥；—所應(yīng)用的或與之交互的預(yù)期的身體部分或組織類型；預(yù)期的用戶特征；預(yù)期的使用條件；—*操作原則.

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict5。2Frequentlyusedfunctions經(jīng)常使用的功能Themanufacturershalldeterminethefrequentlyusedfunctionsthatinvolveuserinteractionwiththemedicaldeviceandrecordthemintheusabilityengineeringfile。制造商應(yīng)確定涉及醫(yī)療器械用戶接口的經(jīng)常使用的功能，并在可用性工程文檔中形成記錄。5.3IdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY與可用性有關(guān)的危害和危害處境的判定5.3o1IdentificationofcharacteristicsrelatedtoSAFETY與安全性有關(guān)的特征的判定Anidentificationofcharacteristicsrelatedtosafety(partofariskanalysis)thatfocusesonusabilityshallbeperformedaccordingtoISO14971:2007,4。2o應(yīng)按照ISO14971:2007的4.2判定與可用性有關(guān)的安全性特征(風險分析的一部分)。Duringtheidentificationcharacteristicsrelatedtosafety,thefollowingshallbeconsidered:一applicationspecification,includinguserproFile(s)(see5o1);and一frequentlyusedfunctions(see5.2)。TheresultsofthisidentificationcharacteristicsrelatedtosafetyshallberecordedintheusabilityengineeringFILEo在判定安全性特征時，應(yīng)考慮下列方面：一應(yīng)用規(guī)范,包括用戶特征(見5.1);—經(jīng)常使用的功能(見5。2)o安全性特征的判定結(jié)果應(yīng)記錄在可用性文檔中。5。3.2IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS已知的或可預(yù)見的危害和危害處境的判定Themanufacturershallidentifyknownorforeseeablehazards(partofariskanalysis)relatedtousabilityaccordingtoISO14971:2007,4。3。TheidentificationofhazardsshallconsiderhazardstoPATIENTS，usersandotherpersons(seeAnnexEandAnnexF).制造商應(yīng)按照ISO14971:2007的4。3判定和可用性有關(guān)的己知的或可預(yù)見的危害(風險分析的一部分)。危害的判定應(yīng)考慮對患者、用戶和其他人員的危害。(見附錄E和附錄F).Reasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinahazardoussituationassociatedwiththemedicaldeviceshallbeidentified.Theseverityoftheresulting

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdictpossibleharmshallbedetermined.應(yīng)判定合理可預(yù)見的可導(dǎo)致和醫(yī)療器械有關(guān)的危害處境的事件序列或組合。應(yīng)確定由此引起的可能損害的嚴重度。Duringtheidentificationofhazardsandhazardoussituations，thefollowingshallbeconsidered:一applicationspecification,includinguserprofile（S）（see5。1）;一卡taskrelatedrequirements;一*contextofuse；一informationonhazardsandhazardoussituationsknownforexistinguserinterfacesofmedicaldevicesofasimilartype,ifavailable；-preliminaryusescenarios；一possibleuseerrors（seeC.2forsomeexamplesofpotentialuseerrors）；一*ifanincorrectmentalmodeloftheoperationofthemedicaldevicecancauseauseerrorresultinginaHAZARDOUSSITUATION；and一*resultsofthereviewoftheusernterface（seeCo4andD。2.2）.在判定危害和危害處境期間，應(yīng)考慮下列各項：—應(yīng)用規(guī)范，包括用戶特征（見5。1）—*與工作有關(guān)的要求-*使用環(huán)境—相似類型醫(yī)療器械的現(xiàn)有用戶接口的己知危害或危險處境的信息（如果有）—初步使用情景—可能的使用錯誤（潛在使用錯誤治一些示例見C.2）—*醫(yī)療器械操作的二個錯誤的構(gòu)思模型是否會引起一個導(dǎo)致危害處境的使用錯誤：—*用戶接口的評審結(jié)果（見C。4和D.2.2）。Theresultsofthisidentificationofhazards，hazardoussituationsandseverityshallberecordedintheusabilityengineeringfile-危害、危害處境和嚴重度的判定結(jié)果應(yīng)記錄在可用性工程文檔中。5.4Primaryoperatingfunctions基本操作功能TheMANUFACTURERshalldeterminethePRIMARYoperatingfunctionsandrecordthemintheusabilityENGINEERINGFILE-制造商應(yīng)確定基本操作功能并記錄在可用性工程文襠中。Theinputstotheprimaryoperatingfunctionsshallincludethefollowing：一frequentlyusedfunctions（see5。2）；and一functionsrelatedtosafetyofthemedicaldevice-基本操作功能的輸入應(yīng)包括：—經(jīng)常使用的功能（見5.2）；

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict—與醫(yī)療器械安全性有關(guān)的功能.5。5UsabilitySpecification可用性規(guī)范ThemanufacturershalldeveloptheusabilitySPECIFICATION-TheUSABILITYSPECIFICATIONshallprovide：一testablerequirementsforusabilityverification；and一testablerequirementsforusabilityoftheprimaryoperatingfunctionsincludingcriteriafordeterminingtheadequacyofriskcontrolachievedbytheusabilityENGINEERINGPROCESS-制造商應(yīng)編制可用性規(guī)范?？捎眯砸?guī)范應(yīng)提供：-用于可用性驗證的可測試的要求：—對基本操作功能可用性的可測試的要求，包括通過可用性工程過程達到的風險控制充分性的判定準則.可用性規(guī)范應(yīng)記錄在可用性工程文擋中.可用性規(guī)范可整合到其他規(guī)范中。Theinputstotheusabilityspecificationshallincludethefollowing：一applicationspecification（see5。1）;一PRIMARYOPERATINGFUNCTIONS（see5。4）；一hazardsandhazardoussituationsrelatedtousability（see5。3）；and一knownorforeseeableuseerrorsassociatedwiththeMEDICALDEVICE-可用性規(guī)范的輸入應(yīng)包括：一應(yīng)用規(guī)范（見5。1）；-基本操作功能（見5.4）—與可用性有關(guān)的危害和危害處境（見5.3）;-與醫(yī)療器械有關(guān)的己知的或可預(yù)見的使用錯誤-Theusabilityspecificationshalldescribeatleast：一usescenariosrelatedtotheprimaryoperatingfunctions,including；-*frequentusescenarios；and一reasonablyforeseeableworstcaseusescenarqs；一userinterfacerequirementsfortheprimaryoperatingfunctions,includingthosetomitigaterisk；一requirementsfordeterminingwhetherprimaryoperatingfunctionsareeasilyrecognizablebytheUSER-可用性規(guī)范至少應(yīng)描述：—與基本操作功能有關(guān)的使用情景，包括：一*經(jīng)常的使用情景；-合理可預(yù)見的最壞的使用情景/方案；-基本操作功能的用戶接口要求，包括降低風險的要求等；

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict—決定基本操作功能是否易于被用戶認知的要求。5。6USABILITYVALIDATIONplan可用性確認計劃ThemanufacturershallprepareandmaintainaUSABILITYVALIDATIONplan。TheUSABILITYvalidationplanshallspecify:一anymethodusedforvalidationoftheusabilityofthePRIMARYOPERATINGFUNCTIONS；一thecriteriafordeterminingsuccessfulvalqatqnoftheusabilityoftheprimaryoperatingfunctionsbasedontheusabilityspecification；and一theinvolvementofrepresentativeintendedusers.制造商應(yīng)制定和保持可用性確認計劃?？捎眯源_認計劃應(yīng)規(guī)定：—用于基本操作功能可用性確認的方法；—決定基于可用性規(guī)范的基本操作功能可用性成功確認的判定準則；—有代表性的預(yù)期用戶的參與.Usabilityvalidationmethodsmaybequantitativeorqualitative。Usabilityvalidationmaybeperformedinalaboratorysetting,inasimulateduseenvironmentorintheactualuseenvironment?？捎眯源_認方法可以是定量的或定性的?？捎眯源_認可以在實驗室、模擬的使用環(huán)境或?qū)嶋H的使用環(huán)境中實施。Theusabilityvalidationplanshalladdress：-frequentusescenarios,and一reasonablyforeseeableworstcaseusescenarqs，thatareidentifiedintheusabilityspecification。TheusabilityvalidationplanshallberecordedintheUSABILITYENGINEERINGFILE-可用性確認計劃應(yīng)闡述：—經(jīng)常的使用情景-合理可預(yù)見的最壞的使用情景上述內(nèi)容的識別見可用性規(guī)范。可用性確認計劃應(yīng)記錄在可用性工程文檔中.5。7UserINTERFACEdesignandimplementation用戶接口的設(shè)計和實施Themanufacturershalldesignandimplementtheuserinterfaceasdescribedintheusabilityspecificationutilizing,asappropriate,usabilityengineeringmethodsandtechniques.制造商應(yīng)設(shè)計和實施可用性規(guī)范中描述的用戶接口，適當時，利用可用性工程的方法和技術(shù).5.8Usabilityverification可用性驗證

產(chǎn)品名可用性評價報告文件編號：JKH-編制:采用標準：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdictAspartofthemedicaldevicedesignverificationPROCESS，theMANUFACTURERshallVERIFYtheimplementationofthemedicaldeviceuserinterfacedesignagainsttherequirementsoftheusabilityspecification°Theresultsoftheverificationshallberecordedinusabilityengineeringfile-作為醫(yī)療器械設(shè)計驗證過程的一部分，制造商應(yīng)按照可用性規(guī)范要求驗證醫(yī)療器械用戶接口設(shè)計的實施?驗證結(jié)果應(yīng)記錄在可用性工程文檔中。5.9Usabilityvalidation可用性確認TheMANUFACTURERshallVALIDATEUSABILITYofthemedicaldeviceaccordingtotheusabilityvalidationplan.TheresultsshallberecordedintheusabltyENGINEERINGFILE-制造商應(yīng)按照可用性確認計劃對醫(yī)療器械的可用性進行確認。其結(jié)果應(yīng)記錄在可用性工程文檔中。Iftheacceptaneecriteriadocumentedintheusabltyvalidationplanarenotmet:一furtheruser[nterfacedesignandimplementationactivitiesshallbeperformed（see5.6）；or一iffurtherimprovementisnotpracticable,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheintendeduseoutweightheriskarisingfromusabilityproblems。IfthisevidencedoesnotsupporttheconclusionthattheMEDIcALbenefitsoutweightheRIsK,thentheRIsKisunacceptable□如果不滿足在可用性確認計劃中形成文件的驗收準則：—應(yīng)進行進步的用戶接口設(shè)計和實施活動（見5。6）；或—如果進步的改進疋不可仃的，制造商可收集資料和文獻并進行評審以確定是否預(yù)期用途的醫(yī)療受益超過了可用性問題引起的風險。如果此證據(jù)不支持醫(yī)療受益超過風險的結(jié)論，則風險是不可接受的